January 17, 2008
FDA Cautions on Over-The-Counter Cough, Cold Medicine for Children
 
The federal Food and Drug Administration (FDA) yesterday issued a Public Health Advisory warning that over-the-counter (OTC) cough and cold medicines should not be used to treat infants and children under the age of 2 years because “serious and potentially life-threatening side effects can occur from such use.” In the same announcement, the FDA said it is reviewing whether such OTC medicines can safely be used for children 2 to 11 years old. Pending completion of that review, the FDA recommends that parents and caregivers of older children should carefully follow dosing directions on any OTC cough or cold medicine and should understand that the products will not cure or shorten the duration of the common cold. Further information on the FDA’s recommendations on use of OTC cough and cold medicines for children is available at http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm.